Kornimate/medical-research-clean huggingface dataset:
efficacy observational study of candesartan cilexetil on hypertensive patients

Conditions: Primary Hypertension

Summary: the purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.


Eligibility criteria:
inclusion criteria: * diagnosis of essential hypertension (mild or moderate as defined in european guidelines of hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to romanian approved atacand spc. written informed consent to allow access and use(analysis) of data collected exclusion criteria: * patients not to be included in the programme: patients who have any contraindication to the product as detailed in romanian approved atacand spc. use of specific concomitant medication known to present a potential safety concern according to romanian approved spc

Keywords: hypertension
'uptime' participation intervention in girls and women with rett syndrome

Conditions: Rett Syndrome

Summary: the aim of the study is to evaluate the feasibility and health-related effects of an individualized 12wk 'uptime' participation intervention in girls and women with rett syndrome. girls and women above 5 years of age with rett syndrome and a confirmed mecp2 mutation will be included. each individual program focuses on participation in enjoyable activities to promote 'uptime' in home, school/day center and community settings. primary outcomes are sedentary time and daily steps. secondary outcomes are gross motor skills, walking capacity, quality of life and participation-level goals. outcomes are evaluated on four occasions: at baseline and after a 6-week interval, immediately following the 12-week intervention program and 12 weeks after the intervention program.


Eligibility criteria:
inclusion criteria: * girls and women above 5 years of age with rett syndrome and a confirmed mecp2 mutation * hoffer ambulation scale levels i-iv exclusion criteria: * girls and women who have undergone orthopedic surgery in the lower extremities within the last 6 months * girls and women who have undergone spinal fusion within the last 12 months
tricuspid regurgitation hamburg cohort

Conditions: Tricuspid Regurgitation

Summary: tricuspid regurgitation (tr) is frequent and has been directly related to high mortality rates. the pathophysiology of tr is mainly functional as it occurs predominantly in the context of left-sided heart disease, pulmonary hypertension, or atrial fibrillation. surgery is currently the primary treatment option in patients with functional tr. however, isolated tricuspid valve surgery is associated with an intolerable high risk of operative mortality and poor outcomes. new transcatheter options could be used in high-surgical risk patients. however, with often severely dilated annuli with a non-planar and elliptical shape, absence of calcification, and proximity of structures, the tricuspid valve anatomy poses many challenges. predictors of outcome are yet to be defined in patients with tr in order to improve risk prediction for the different treatment modalities (medical, surgical, interventional). the tricuspid regurgitation hamburg cohort (truth) aims to monitor patients with relevant tr, irrespective of the underlying etiology or therapeutic approach. in addition to available evidence from previously published clinical trials, elaborate prospective clinical registries, such as truth, that monitor clinical routine and current practice, will be of significant importance to further enhance therapeutic options.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent in accordance with good epidemiological practice and local legislation. * individuals over the age of 18 years. * patients with clinically relevant tricuspid regurgitation (≥ severe tr, at least grade iii of v) exclusion criteria: * insufficient knowledge of the german language, to understand study documents and interview without translation * physical or psychological incapability to cooperate in the investigation
application circulating tumor dna dynamic monitoring in clinical treatment of metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: next-generation sequencing and whole transcriptome rna sequencing were used to detect genomic variation and expression in tissues or blood, respectively. the treatment outcome of single targeted therapy or combined with immunotherapy was observed and followed up. through this study, we intend to achieve rna molecular classification of chinese mrcc patients and to evaluate the correlation between ctdna level, rna molecular classification and treatment outcome, provide reference for metastatic rcc precise diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with renal cell carcinoma confirmed by pathology, including clear renal cell carcinoma and type i papillary renal cell carcinoma, type ii papillary renal cell carcinoma, chromophobe renal cell carcinoma and renal cell carcinoma with sarcomatoid differentiation, etc * have distant metastasis * metastatic rcc * eastern cooperative oncology group 0 to 1 * no obvious abnormality was found in blood routine examination, coagulation and liver and kidney function exclusion criteria: * • previously received systematic treatment * failure to obtain baseline tumor tissue / blood samples * a history of infection with human immunodeficiency virus, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation, or have a history of organ transplantation * a history of allergy to disease treatment drugs * during lactation or pregnancy

Keywords: metastatic renal cell carcinoma molecular classification ctdna dynamic monitoring targeted therapy targeted therapy combined with immunotherapy
the usefulness of postprandial triglyceride for assessment of cardiovascular risk

Conditions: Diabetes; Prediabetes

Summary: the hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (cvd). recently, postprandial triglyceride (tg) levels draw an attention as a superior predictor of cvd because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein. we aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. in addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.


Eligibility criteria:
inclusion criteria: * age : 19 \~ 70 yrs * type 2 diabetes : hba1c \<10% * prediabetic state : hba1c 5.7\~6.4% exclusion criteria: * type 1 diabetes, secondary diabetes * dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users * thyroid disease with abnormal thyroid function test * liver disease with abnormal liver function test * severe kidney disease * pregnant or lactating women * current smoker * severe obesity

Keywords: postprandial period triglyceride diabetes mellitus, type 2 prediabetic state
effect of low level laser on orthodontic canine retraction

Conditions: Dental Malocclusion

Summary: the aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of lllt exhibited differences in amount and rate of orthodontic tooth movement.

fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years were included. they had a clinical indication for bilateral extraction of at least first maxillary premolars. using a split mouth design, maxillary left and right sides were randomly divided into two groups. in group 1, lllt was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 joule (j) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. in group ii, laser was applied from buccal side only at 5 points through the same order with a dose of 4 j per session. in both protocols, maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mw, 25 j/cm2, 8 seconds/ point, 0.8 j/point. both sides were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring. in both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. amount and monthly rate of maxillary canine retraction and degree of anchorage loss were determined by direct intraoral and indirect 3d digital models measurements. evaluations were undertaken immediately before initiating retraction (t0), after 4 weeks (t1), after 8 weeks (t2), after 12 weeks (t3), after 16 weeks (t4), after 20 weeks (t5), and after 24 weeks (t6). significance level was set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * complete permanent dentition (3rd molars excluded). * the age was ranged from 15 -25 years. * malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction. * good oral hygiene and periodontal health. exclusion criteria: * patients who diagnosed to have an indication for non-extraction approach. * serious systemic diseases and/or long term medications that could interfere with otm. * previous orthodontic treatment. * poor oral hygiene or periodontally compromised patients. * craniofacial anomalies or history of parafunctional habits.

Keywords: low level laser therapy orthodontic tooth movement canine retraction two protocols and energy doses
the use of jet injection lidocaine for blood draws in young children

Conditions: Pain

Summary: this study looks at the use of jet injection lidocaine (j tip) for pain during blood draws in children ages 6 and younger. the investigators will use video observation of patients to asses their pain during lab draws using either 1) jet injected lidocaine ( j tip) 2) pain ease spray 3) pain ease spray plus the j tip noise.

no change since last report.

Eligibility criteria:
inclusion criteria: * children aged 6 months-6 years seen in the children's hospital of wisconsin outpatient laboratory that have an order for venipuncture for a blood draw exclusion criteria: * previous adverse reaction to lidocaine or pain ease spray * pre-existing skin lesion at site of blood draw * needle stick for iv insertion or lab draw that has already occurred at current hospital visit * patients who are physically unable to move their arms or legs * patients who are unable to cry * patients with connective tissue disorders that predispose to easy bruising * patients with bleeding disorders

Keywords: pain children venipuncture j tip lidocaine video observation
lenstec softec hd posterior chamber intraocular lens clinical investigational protocol

Conditions: Cataract

Summary: the objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the lenstec softec hd posterior chamber intraocular lens (iol) following one year of post-operative assessment.

the softec hd posterior chamber iol is designed for the treatment of aphakia. the lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. the intended benefit of the softec hd posterior chamber iol is to provide enhanced vision.

Eligibility criteria:
inclusion criteria: * cataract requiring cataract extraction * study iol to only be implanted in 1 eye * distance bcva 20/40 or worse or glare acuity worse than 20/30 * ability to comply with study follow-up requirements exclusion criteria: * patients with serious corneal disease, previous surgery or serious systemic disease * ocular condition that could impact vision after cataract surgery * pregnant or lactating women * use of ocular or systemic medications that could impact vision

Keywords: cataract surgery iol intraocular lens
a phase 2 study of obe001 versus placebo in the delay of preterm birth

Conditions: Preterm Labor

Summary: the primary objective of this study is to assess the efficacy of a single dose of obe001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

the study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34\^0/7 and 35\^6/7 weeks of gestation. the study will be in 2 parts as follows: * from screening until the day of delivery (including a treatment period up to seven days) * a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later). in addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.

Eligibility criteria:
inclusion criteria: * gestational age (ga) between 34\^0/7 and 35\^6/7 weeks. * subjects with symptoms of preterm labour. * subjects with a singleton pregnancy. exclusion criteria: * foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy. * any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery. * use of cervical cerclage or a pessary in situ in the current pregnancy. * the subject has any condition which in the opinion of the pi constitutes a risk or a contraindication for the participation of the subject in the trial.

Keywords: premature obstetric labor premature birth
neo-tace-haic for high-risk bclc a stage hcc (neoconcepta)

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) patients is a common disease in the east asia. although resection was recommend for early stage (bclc a stage) patients according to the bclc (barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. however, the clinical value is still undertermined. recently, folfox (oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (haic) exhibited high response rate for unresectable hcc. pilot study showed tace combined haic (tace-haic) had better tumor response, with low progression disease rate. whether tace-haic would improve survival for bclc a stage patients with high-risk factors is need to further to study. a randomized clinical trial compared neo-tace-haic with surgery versus surgery alone is aimed to answer this question.


Eligibility criteria:
inclusion criteria: * age 18-75 years; * bclc a stage with high-recurrence risk factor; * patients with resectable primary hepatocellular carcinoma; * child-pugh a or b (7 score) liver function; * the volume of residual liver more than 30% exclusion criteria: * • with unresectable hcc * pregnant woman or sucking period; * with other malignant cancer; * received anti-hcc therapy before this study
effect of linagliptin on insulin sensitivity and pancreatic beta cell function in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance

Summary: this study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. in addition, the effect of linagliptin on pancreatic function will be studied.

this is a prospective study of 30 patients with type 2 diabetes mellitus (t2dm) . patients with t2dm in the age group 30-65 years and duration of diabetes less than five years will be screened. after exclusion, those who meet the inclusion criteria will be included in the study. once eligibility criteria are confirmed, patients will be educated about their disease and will be advised weight maintenance diabetic diet and exercise throughout the study period. patients will be randomized to three groups - linagliptin (5mg od) or voglibose (0.2mg tds) or placebo od. metformin will be continued in all patients. to evaluate the effect of linagliptin on insulin sensitivity and beta cell function, independent of changes in hba1c, the voglibose group is included. each group will have 10 patients and will be followed up for 6 months. both patients and physicians will be blinded to the treatment. after having written informed consent, a detailed history and a thorough clinical examination will be done in all subjects including measurement of height, weight, body mass index and waist circumference. hemoglobin, liver function tests, renal function tests, lipid profile, hba1c, fasting plasma insulin , c-peptide, homeostasis model assessment-insulin resistance index(homa-1r) and homeostasis model assessment-beta cell function index (homa-β) will be done at baseline. a euglycemic hyperinsulinemic clamp study and a mixed meal test will be performed in all patients (on different days) at baseline and after 6 months of follow up. biochemical parameters will be measured again 6 months after therapy. fasting and post-prandial blood glucose will be done monthly for 6 months.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus (according to ada guidelines) * age between 30-65 years * duration of diabetes less than five years * bmi of between 20 and 40 kg/m2 * hba1c level of \< 7.5% * on metformin monotherapy for at least 6 weeks exclusion criteria: * history of ketoacidosis * hepatic impairment (defined as plasma aminotransferase elevations of more than 3 times upper limit of normal) * renal failure (defined as serum creatinine more than 1.5 mg/dl) * coronary artery disease or heart failure * cerebrovascular disease or stroke * anemia (hb\< 10 g/dl) * those who requires insulin therapy hba1c \>7.5% * presence of macular edema * pregnant or lactating women * patients who have received dipeptidyl peptidase 4 (dpp-4) inhibitor therapy within last 3 months

Keywords: type 2 diabetes mellitus insulin sensitivity- hyperinsulinemic euglycemic clamp pancreatic beta cell function linagliptin voglibose mixed meal test glp-1 response
brief cognitive behavioral therapy to treat itch rumination "itch cbt" in eczema

Conditions: Atopic Dermatitis

Summary: the main purpose of this study is to adapt cognitive behavior therapy (cbt) to improve itch in children with eczema.

eczema is characterized by chronic itch. many children develop a chronic focus (rumination) on their itch. rumination is a maladaptive method of responding to distress, in which the individual thinks obsessively about the source of distress. the rumination on chronic itch in eczema can have detrimental effects on one's quality of life, as well as induce significant anxiety about when itch will return, how long it will last, and how it will affect physical and social functioning. cognitive behavior therapy (cbt) is a frontline treatment for rumination, as it focuses on teaching strategies so that the individual can examine distressing thoughts objectively and determine their validity, replace negative thinking patterns with more adaptive thought patterns, and increase the individual's awareness to their problematic thought patterns. additionally, cbt helps the individual to implement behavioral strategies to cope with possibly anxiety-inducing situations, such as scratching while trying to go to sleep. the investigators hypothesize that an itch cbt intervention is an effective, non-medication-based, easy to implement strategy to improve itch in children with eczema.

Eligibility criteria:
inclusion criteria: * moderate to severe atopic dermatitis \[assessed by patient oriented eczema measure (poem)score of \>-8 or nrs itch score of \>= 4\]. * english speaking. * currently receiving treatment at lurie children's hospital for atopic dermatitis. * parent or guardian available to participate in protocol. * have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can be used to access zoom conference technology for telemedicine visits. exclusion criteria: * inability to comprehend and complete questionnaires. * history of intellectual disability or psychosis.

Keywords: pediatric
use of acellular dermal in the incarcerated inguinal hernia tension-free reconstructions

Conditions: Incarcerated Inguinal Hernia

Summary: incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.using traditional tension hernia reparation, the recurrence rate were as high as 30%. in recent years, biological materials especially acellular matrix materials (acellular dermal matrix, adm) in resisting the infection, has become a research hotspot. in the project, the investigators try to address the role of adm in incarcerated inguinal hernia patients.

observation indicator: 1. recurrence rate after operation 2. incidence rate of complications 3. postoperative hospital stay 4. hospitalization costs 5. self-evaluation of gastroesophageal reflux symptoms and quality of life(qol) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Eligibility criteria:
inclusion criteria: * clinical diagnosis of incarcerated hernia * randomly select patch agreed by patients and family members exclusion criteria: * severe organ dysfunction * no-tolerate anesthesia * no-suitable for operation * glucocorticoid with long-term use * sever intraperitoneal adhesion existed * spirit disease patients * automatically exit
evaluation of the spyglass ds for detection of residual pancreatic calculations

Conditions: Pancreatitis, Chronic

Summary: the purpose of the study is to assess the efficacy of the spyglass ds for the detection of residual pancreatic calculations after endoscopic treatment.


Eligibility criteria:
inclusion criteria: * aged 18 and over; * with chronic calcifying pancreatitis; * having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones; * having given free, informed and written consent; * being affiliated to a social security scheme or beneficiary of such a scheme. exclusion criteria: * contraindications to performing an upper digestive endoscopy; * haemorrhagic disease, haemostasis and coagulation disorder (pr \ 40 s and platelets \<60,000 / mm3; * pregnant or breastfeeding woman; * adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision; * person subject to a safeguard measure.